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Resources – Trial Master File Reference Model Discussion Forum
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uagb-faq-inactive-other-true uagb-faq__wrap uagb-buttons-layout-wrap uagb-faq-equal-height" data-faqtoggle="true" role="tablist"> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-1ccda550" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>TMF Reference Model </strong></span></div><p class="uagb-faq-content"><a href="https://tmfrefmodel.com/download/5087/?tmstv=1694094816">TMF Reference Model V3.3.1</a>, Released 11-AUG-2023, Excel spreadsheet<br><a href="https://tmfrefmodel.com/download/5092/?tmstv=1694095240">TMF Reference Model v3.3.1 Release Notes</a>, Published 11-AUG-2023<br><a rel="noreferrer noopener" href="https://tmfrefmodel.com/download/5034/?tmstv=1684330814" target="_blank">TMF Reference Model V3.3</a>, Released 31-Mar-2023, Excel spreadsheet<br><a rel="noreferrer noopener" href="https://tmfrefmodel.com/download/5037/?tmstv=1684330525" target="_blank">TMF Reference Model v3.3 Release Notes</a>, Published 31-Mar-2023<br><a href="https://tmfrefmodel.com/download/4025/">TMF Reference Model V3.2.1</a>, <strong>Released 01-Mar-2021, Excel spreadsheet</strong><br><a href="https://tmfrefmodel.com/download/4028/">TMF Reference Model V3.2.1 Release Notes</a>, <strong>Released 01-Mar-2021</strong><br><a href="https://tmfrefmodel.com/download/3927/">TMF Reference Model V3.2.0</a>, Released 02-Nov-2020, Excel spreadsheet<br><a href="https://tmfrefmodel.com/download/3932/">TMF Reference Model V3.2.0 Release Notes</a>,聽Released 02-Nov-2020(see revised Implementation Guide below)<br><strong>Please note</strong>: Older resources can be found on our <a href="https://tmfrefmodel.com/resources-archive">Resources Archive</a> page.</p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-394a9b41" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Project Team All-Hands Meetings</strong></span></div><p class="uagb-faq-content"><a href="https://tmfrefmodel.com/download/4762/?tmstv=1666082409">October 13, 2022 – Slide Deck</a> <a href="https://www.cdisc.org/events/webinar/tmf-reference-model-general-meeting">CDISC Recording</a> <strong>NEW</strong><br><a href="https://tmfrefmodel.com/download/4767/?tmstv=1666093604">June 27, 2022 – Slide Deck</a> <a href="https://www.cdisc.org/events/webinar/tmf-reference-model-group-and-cdisc-affiliation-whats-next">CDISC Recording</a><br><a rel="noreferrer noopener" href="https://tmfrefmodel.com/download/4623/" target="_blank">May 9, 2022 – Slide Deck</a> <a rel="noreferrer noopener" href="https://youtu.be/_22hzbARe94" target="_blank">YouTube Recording</a><br><a href="https://tmfrefmodel.com/download/4544/">March 14, 2022 – Slide Deck</a> <a href="https://youtu.be/lsPenoK86vs">YouTube Recording</a><br><a href="https://tmfrefmodel.com/download/4360/">January 24, 2022 – Slide Deck</a>聽 <a href="https://youtu.be/DFcLAW0moNo">YouTube Recording</a> <br><a href="https://tmfrefmodel.com/download/4293/">December 13, 2021 – Slide Deck</a>聽 <a href="https://youtu.be/FQdtdJ0rqD4">YouTube Recording</a><br>聽<a href="https://tmfrefmodel.com/download/4246/">September 13, 2021 – Slide Deck</a>聽 聽<a href="https://www.youtube.com/watch?v=TrHnK1R1npE">YouTube Recording</a><br><a href="https://tmfrefmodel.com/download/4209/">July 19, 2021 – Slide Deck</a>聽 聽<a href="https://youtu.be/EGbtV8ddTV4">YouTube Recording</a><br><a href="https://tmfrefmodel.com/download/4181/">June 7, 2021 – Slide Deck</a>聽 聽<a href="https://youtu.be/-Ai1J5dawMY">YouTube Recording</a><br><a href="https://tmfrefmodel.com/download/4119/">April 19, 2021 – Slide Deck</a>聽 聽 <a href="https://www.youtube.com/watch?v=I-Vg9z907g0">YouTube Recording</a> 聽 <strong style="color: #ff0000;">聽聽</strong><br><a href="https://tmfrefmodel.com/download/4021/">March 1, 2021 – Slide Deck </a>聽聽<a href="https://www.youtube.com/watch?v=0fuduchStqg">YouTube Recording</a> 聽 <strong style="color: #ff0000;">聽聽</strong><br><a href="https://tmfrefmodel.com/download/3952/">January 11, 2021 – Slide Deck</a>聽 聽 聽<a href="https://www.youtube.com/watch?v=VUgw8VVTAOw">YouTube Recording</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-26-OCT-2020.pdf">October 26, 2020 – Slide Deck</a>聽 聽 <a href="https://www.youtube.com/watch?v=qASQNsFxr98">YouTube Recording</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-21-SEP-2020.pdf">September 21, 2020 – Slide Deck</a> 聽聽 <a href="https://www.youtube.com/watch?v=e0Dzp014ll8">YouTube Recording</a><br>聽<a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-27-JUL-2020.pdf">July 27, 2020 – Slide Deck</a>聽 聽 <a href="https://youtu.be/-aOosM4YC7o">YouTube Recording</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-22-JUN-2020.pdf">June 22, 2020 – Slide Deck</a>聽 聽 <a href="https://youtu.be/gD9ClbDbQN8">YouTube Recording</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-11-MAY-2020.pdf">May 11, 2020 – Slide Deck</a>聽 聽 聽<a href="https://youtu.be/McmHuivKrjA">YouTube Recording</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-30-MAR-2020.pdf">March 30, 2020 – Slide Deck</a>聽 聽 聽 <a href="https://youtu.be/9XCeIlmDDAA">YouTube Recording</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-03-FEB-2020.pdf">February 3, 2020</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-18-NOV-2019.pdf">November 18, 2019</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-23-SEP-2019.pdf">September 23, 2019</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-03-JUN-2019.pdf">June 3, 2019</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Meeting-01-APR-2019.pdf">April 1, 2019</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/2019/02/tmf-rm-meeting-11-feb-2019.pdf">February 11, 2019</a><br>Meeting recordings (where available) can be accessed on our <strong>YouTube</strong> channel: click <a href="https://www.youtube.com/channel/UCXN-rF3ufcvhOoILePrSj-Q">HERE</a></p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-fd6f6bc4" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Training Resources</strong></span></div><p class="uagb-faq-content">TMF Reference Model Training, <a rel="noreferrer noopener" href="https://youtu.be/17kJ3_elZQM" target="_blank">Part 1: History and Current Status</a><br>TMF Reference Model Training, <a href="https://youtu.be/e126umK5hPc" target="_blank" rel="noreferrer noopener">Part 2: Definition, Application, Maintenance, Implementation</a></p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-207b1daf" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Resources for Current Versions of the Model</strong></span></div><p class="uagb-faq-content"><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Deliverable-Implementation-Guide-v2-02-Nov-2020.pdf">TMF Reference Model Implementation Guidance</a>: Provides a framework for implementing the model in your organization (v2.0 Approved 02-November-2020)<br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Deliverable-User-Guide-v2-2020-11-18.pdf">TMF Reference Model User Guide</a> – Guide to the TMF Reference Model (v2 Approved 18-Nov-2020) <strong>REVISED</strong><br><a href="https://tmfrefmodel.com/wp-content/uploads/2019/02/2019-02-tmf-reference-model-v3.1.0.pdf">TMF Reference Model v3.1.0 Presentation</a> – Overview of the Reference Model <strong>REVISED</strong><br><a href="https://tmfrefmodel.com/wp-content/uploads/2016/06/process-map-jul-2011.pdf">TMF Reference Model Process Maps</a>: Used in the development of Reference Model to align TMF artifacts to trial processes<br><a href="https://youtu.be/i8gb_iM8l-8">The Evolution of the TMF Reference Model v3.0</a>: Recording of webinar delivered in July 2015</p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-c61201cd" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>TMF Plan Template</strong></span></div><p class="uagb-faq-content"><a href="https://tmfrefmodel.com/download/4789/?tmstv=1667384522">TMF Plan Template</a>: Suggested structure and outline for a Trial Master File Plan聽(v2.0 Approved 21-October 2022)<br><a rel="noreferrer noopener" href="https://goo.gl/forms/NyEUfMcAVuKXJ2np2" target="_blank">TMF Plan Template Feedback</a>: Click on <a rel="noreferrer noopener" href="https://goo.gl/forms/NyEUfMcAVuKXJ2np2" target="_blank">LINK</a> to provide feedback on the TMF Plan<br><a href="https://tmfrefmodel.com/download/4792/?tmstv=1667384609">TMF Plan Change Log</a>: List of changes made in v2.0 of TMF Plan Template<br><a href="https://tmfrefmodel.com/download/4796/?tmstv=1667384673">TMF Plan Version Comparison</a>: Document showing tracked changes between v1.0 and v2.0</p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-4caf5b0e" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>eTMF Exchange Mechanism Standard (eTMF-EMS)</strong></span></div><p class="uagb-faq-content"><a href="https://youtu.be/FoDK5Yw7tq0">Recording: Meeting of TMF-EMS Change Control Board</a> 28-Jul-2022 <strong>NEW</strong><br><a href="https://youtu.be/xbCaTUJ1VuY">Recording: Meeting of TMF-EMS Change Control Board</a> 31-May-2022<br><a href="https://tmfrefmodel.com/download/4329/">eTMF-EMS Specification v1.0.2</a> <strong>Published 21-Jan-2022</strong><br><a href="https://tmfrefmodel.com/download/4334/">eTMF-EMS Release Notes r22.1</a> <strong>Published 21-Jan-2022</strong><br><a href="https://youtu.be/pQvuZEljYp8">Recording: Exchange mechanism Standard Survey Results</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/eTMF-EMS-Specification-v1.0.1.pdf">eTMF-EMS Specification v1.0.1</a> Released 25-OCT-2019<br><a href="https://tmfrefmodel.com/wp-content/uploads/eTMF-EMS-Release-Notes-v19.3.2.pdf">eTMF-EMS Release Notes r19.3.2</a> 25-OCT-2019<br><a href="https://tmfrefmodel.com/wp-content/uploads/eTMF-EMS-r19.1.5-Release-Notes.pdf">eTMF-EMS Release Notes r19.1.5</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/2018/06/etmf-ems-v1-0.pdf">eTMF-EMS Specification v1.0</a>, Released 14-JUN-2018<br><a href="https://github.com/TmfRef/exchange-framework">XML Exchange Structure</a> (hosted on GitHub)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2018/07/2018-0622-etmf-ems-dia-launch.pdf">eTMF-EMS Launch Presentation</a> at DIA Global 22-JUN-2018 (PowerPoint)</p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-32b11f9f" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>TMF Tools</strong></span></div><p class="uagb-faq-content">Email Communications in the TMF: <a href="https://tmfrefmodel.com/download/3962/">Webinar Slides</a>聽 聽<a href="https://youtu.be/p7L2wUcP2i8">YouTube Recording</a> (webinar held 15-Jan-2021)<br><a href="https://tmfrefmodel.com/download/4034/">Responses to Questions</a>: Email Communications in the TMF<br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Deliverable-Real-World-Studies-Document-Index-v1-2020-07-29.xlsx">Real-World Studies Document Index</a> Provides a proposed Document Index for use on real-world studies, based on the TMF Reference Model for clinical trials (v1.0 Approved 29-July-2020)<br><a href="https://tmfrefmodel.com/wp-content/uploads/TMF-RM-Deliverable-eMail-Communications-Guidance-v1-2020-07-31.pdf">Industry Guidance: Email Communications</a> Guidance from the TMF Reference Model Project on the management of email communications in clinical studies (v1.0 Approved 29-July-2020)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/05/tmf-rm-deliverable-guidance-for-date-conventions-2017-02-15.docx">Date Conventions Guidance</a>: Guidance notes to be used with Date Conventions columns (Approved 15-Feb-2017)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/02/tmf-rm-deliverable-tmf-quality-control-2016-10-12.docx">TMF Quality Control</a>: Toolkit to help prepare a TMF quality control programme (Approved 12-Oct-2016)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/02/tmf-quality-control-presentation.pptx">TMF Quality Control Presentation</a>: Powerpoint slides presented to group meeting November 7, 2016<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/01/tmf-rm-deliverable-inspection-readiness-raci-2016-11-09.xlsx">Inspection Readiness RACI</a>: RACI Toolkit to help prepare TMF for regulatory inspections (Approved 09-Nov-2016)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/01/2017-01-09-inspection-preparation-presentation.pptx">Inspection Readiness Presentation</a>: Powerpoint slides presented to group meeting January 9, 2017<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/03/etmf-selection-rfp-master-v1-0.xlsx">eTMF Selection – Request for Proposal Template</a> (co-authored by Scientific Archivists Group, TMF Reference Model and Pocket EDMS, March 2017<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/04/tmf-rm-deliverable-inspection-faqs.xlsx">Inspection FAQs</a>: Common inspection questions with answers, and regulatory resource list (Approved 15-Mar-2017)<br><br><a href="https://tmfrefmodel.com/wp-content/uploads/2014/09/tmfrm_metrics-101_27aug141.pdf">Metrics 101 </a>– How to Implement a TMF Metrics Program (PDF File)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2014/09/tmfrm_metrics-101_27aug14.pptx">Metrics 101</a> – How to Implement a TMF Metrics Program (PPT File)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2014/09/tmfrm_metrics-definitions_27aug14.xlsx">Metrics Definitions</a> – Recommended Metrics for your TMF Metrics Program (XLS File)</p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-c3552ad5" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Annual TMF Reference Model Survey</strong></span></div><p class="uagb-faq-content"><a href="https://tmfrefmodel.com/download/4910/?tmstv=1675786303">2022 TMF Survey Overview</a> (PDF File) <strong>NEW</strong><br><a href="https://tmfrefmodel.com/download/4914/?tmstv=1675786620">2019 TMF Survey Overview</a> (PDF File)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2016/10/2015-tmf-survey-overview.pdf">2015 TMF Survey Overview</a> (PDF File)</p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-cba8f6bf" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Miscellaneous Resources</strong></span></div><p class="uagb-faq-content"><a href="https://tmfrefmodel.com/download/4804/?tmstv=1667387117">Webinar Summary – EU Clinical Trial Regulation and its Impact on the TMF Content & Process</a> <strong>NEW</strong><br><a rel="noreferrer noopener" href="https://tmfrefmodel.com/download/4860/" target="_blank">TMF Reference Model Initiative Charter</a> (current version) <strong>REVISED</strong> <strong>v4</strong><br><a rel="noreferrer noopener" href="https://youtu.be/ZhAAgc-HNWc" target="_blank">Webinar Recording – EU Clinical Trial Regulation and its Impact on TMF Content & Process</a><br><a href="https://tmfrefmodel.com/download/4338/">Position Paper on CDISC Affiliation</a>聽<br><a href="https://tmfrefmodel.com/download/4213/">Applicability of 21CFR11 to Third Parties – FDA Q&A</a> (19-JUL-2021)聽<br><a href="https://www.youtube.com/watch?v=Qb8CaPH_hJ8">Future-proofing the TMF Reference Model: Discussion during General Meeting</a> (19-Apr-2021)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2019/02/eu-2018-12-tmf-guidance.pdf">Guideline on the Content, Management & Archiving of the Clinical TMF</a> (06-Dec-2018)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2018/12/UK-MHRA-q-a-TMF-Summit-2018-12.pdf">MHRA Q&A Document</a> from ExL TMF Summit, London, October 2018<br><a href="https://www.nihcollaboratory.org/sites/CbyC/SitePages/Home.aspx">Duke Clinical Research Institute Resources</a>聽External resource – Not a project deliverable(14-Nov-2018)<br><a href="https://clinregs.niaid.nih.gov/">NIH Resources for Clinical Research</a> 聽External resource – Not a project deliverable (01-Aug-2018)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2018/04/2018-04-10-tmf-rm-summary-for-ich.pdf">Presentation to ICH M2 Expert Working Group</a> (10-Apr-2018)<br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/11/tmf-exchange-mechanism-summary.pdf">TMF Exchange Mechanism Status Summary</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/2017/10/mhra-tmf-focus-day-summary.pptx">2017 MHRA TMF Focus Day Summary</a><br><a href="http://tmfrefmodel.com/about/tmf-reference-model-steering-committee/">Steering Committee Members</a><br><a href="https://tmfrefmodel.com/wp-content/uploads/2018/02/tmf-reference-model-version-control-policy-v1-1.pdf">TMF Reference Model Version Control Policy</a><br><a href="https://tmfrefmodel.com/download/4855/">Steering Committee Charter</a> <strong>(Revised 2023 v4)</strong></p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-0145b14f" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Published Articles</strong></span></div><p class="uagb-faq-content"><a href="http://www.appliedclinicaltrialsonline.com/appliedclinicaltrials/article/articleDetail.jsp?id=843704&pageID=1">TMF Reference Model Standard = Process Efficiency</a> <em>(published Applied Clinical Trials, May 2014)</em><br><a href="https://tmfrefmodel.com/wp-content/uploads/2015/02/tmf-reference-model_22aug12.ppt">TMF Reference Model Presentation</a>: <em>Overview of the TMF Reference Model, Published August 2012</em></p></div> <div class="wp-block-uagb-faq-child uagb-faq-child__outer-wrap uagb-faq-item uagb-block-ee5012ce" role="tab" tabindex="0"><div class="uagb-faq-questions-button uagb-faq-questions"><span class="uagb-icon uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M432 256c0 17.69-14.33 32.01-32 32.01H256v144c0 17.69-14.33 31.99-32 31.99s-32-14.3-32-31.99v-144H48c-17.67 0-32-14.32-32-32.01s14.33-31.99 32-31.99H192v-144c0-17.69 14.33-32.01 32-32.01s32 14.32 32 32.01v144h144C417.7 224 432 238.3 432 256z"></path></svg></span><span class="uagb-icon-active uagb-faq-icon-wrap"><svg xmlns="https://www.w3.org/2000/svg" viewBox="0 0 448 512"><path d="M400 288h-352c-17.69 0-32-14.32-32-32.01s14.31-31.99 32-31.99h352c17.69 0 32 14.3 32 31.99S417.7 288 400 288z"></path></svg></span><span class="uagb-question"><strong>Prior Versions of the TMF Reference Model</strong></span></div><p class="uagb-faq-content">See聽<a href="https://tmfrefmodel.com/resources-archive">Resources Archive</a>聽page</p></div> </div> </div><!-- .entry-content .clear --> </article><!-- #post-## --> </main><!-- #main --> </div><!-- #primary --> <div class="widget-area secondary" id="secondary" itemtype="https://schema.org/WPSideBar" itemscope="itemscope"> <div class="sidebar-main" > <aside id="bbp_topics_widget-2" class="widget widget_display_topics"><h2 class="widget-title">Recent Discussion Topics</h2> <ul class="bbp-topics-widget newness"> <li> <a class="bbp-forum-title" href="https://tmfrefmodel.com/forums/topic/econsent-validation-documents">eConsent validation documents</a> <div>4 days, 3 hours ago</div> </li> <li> <a class="bbp-forum-title" href="https://tmfrefmodel.com/forums/topic/10-02-05-data-capture-final-subject-data">10.02.05 Data Capture – Final Subject Data</a> <div>1 week ago</div> </li> <li> <a class="bbp-forum-title" 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